Regulatory Affairs Manager

Freudenberg Medical; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading medical device company is seeking a Regulatory Affairs Manager to oversee regulatory strategies, submissions, and compliance. This role requires extensive regulatory experience, particularly with FDA submissions, and offers a chance to make a significant impact in healthcare.

Benefits

401K Match

Education Reimbursement

Corporate Events

Diversity & Inclusion

Sustainability & Social Commitment

Qualifications

• Minimum 8 years of regulatory experience with medical devices.
• Successful FDA submissions required.

Responsibilities

• Oversee regulatory strategies and submissions for FDA and other regions.
• Lead and supervise the Regulatory Affairs team.

Skills

Regulatory Experience

Managerial Skills

FDA Regulations

ISO Standards

Education

BSc in Regulatory Sciences

Job description

Join to apply for the Regulatory Affairs Manager role at Freudenberg Medical

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a diverse environment where everyone can thrive. Be surprised and experience your own wow moments.

At Freudenberg Medical, we make products that save and improve lives worldwide. We are a leading provider of medical device design and manufacturing with over 2,500 employees. Innovation, quality, lean manufacturing, and technological advancement are at our core. Join us to make a difference in healthcare.

Benefits include:

• 401K Match: Save for retirement with company support.
• Sustainability & Social Commitment: Support social and sustainable projects.
• Diversity & Inclusion: An inclusive environment recognizing diversity as a success factor.
• Education Reimbursement: Financial aid for career development.
• Corporate Events: Celebrating success together.

Location: United States of America - Remote, Carpinteria, CA, or other locations.

Position Overview:

You will support our team as a Regulatory Affairs Manager, overseeing regulatory strategies, submissions, team supervision, compliance, and interactions with regulatory bodies.

Responsibilities include:

• Providing regulatory guidance and overseeing submissions for FDA, Health Canada, MDR Notified Bodies, and other regions.
• Leading and supervising the Regulatory Affairs team, establishing priorities and ensuring resources.
• Serving as regulatory lead for cross-functional projects, maintaining registrations, and ensuring compliance with standards and regulations.
• Managing regulatory reporting, audits, and recalls, and ensuring adherence to EU MDR and other directives.
• Training employees and liaising with authorities for submissions and compliance.

Qualifications:

• BSc in Regulatory Sciences or related field, with RA coursework/seminars.
• Minimum 8 years of regulatory experience with medical devices, successful FDA submissions.
• Experience with global regulatory requirements, FDA regulations, ISO standards, and managerial skills.
• Willingness to travel to Carpinteria, CA as needed.

We are an equal opportunity employer committed to diversity and inclusion.